CompletedNCT05467059TinniNapUpdated Mar 29, 2023

Evaluation of Potential Causes of Nap Modulated Tinnitus

An observational study in Tinnitus, Hearing Disorders and Ear Diseases, sponsored by Robin Guillard EIRL. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Robin Guillard EIRL · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 37
Ages: 18 Years to 75 Years
Sex: All

Study summary

The proposed research is a non-interventional study made to evaluate different measurements on 1 group of participants, before and after taking a nap, aiming to potentially guide future investigations on nap-modulated tinnitus to better understand this phenomenon.

The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.

Read the detailed description

- Background : Tinnitus is a really important concern due to its high prevalence (10% world population) and its deteriorating effects on life quality. Subjective tinnitus still remains a scientific enigma because of its partial elucidation. The limited knowledge on its causes can be partially attributed to its intrinsic heterogeneity. In questionnaires previous to this study, 34% of participants showed a characteristic symptomatology of interactions between tinnitus and their sleep : they feel their tinnitus at its maximum intensity after sleeping periods (nap and sleep). In most cases they describe a frank rise of the intensity, compared in scientific papers to the "exploding head syndrome". Therefore this study aims to determine what are the main physiopathological processes correlated to the rises of tinnitus
- Objectives : Estimate the correlations between tinnitus intensity changes (before and after the nap) and the number of sleep apneas. Secondary measurements are described in the outcome field.

Conditions studied

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

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Keywords

Nap modulated tinnitus
Sleep modulated tinnitus
sleep apneas

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 57 observational studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

This is the only study on the registry with Robin Guillard EIRL as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Study population is recruited through questionnaires done on different platforms including : SIOPI app, previous potential participants or associations. A lesser part of the study group comes from suggestions of ENTs/Doctors.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Affiliated participant or beneficiary of a social security scheme
Acceptation of protocol and signature of non-opposition
Frankly nap-modulated tinnitus (increase of intensity after napping)
Tinnitus maskable by white noise equal or inferior to 85 dB

Exclusion criteria

Exclusion Criteria:

Persons under juridic protection (guardianship or safeguard of justice)
Clear cognitive incapacity (not understanding/nor apprehend the study tasks)
Pregnancy or breast feeding
Epilepsia
Non-equilibrated chronic metabolic pathology
Non-equilibrated psychiatric pathology
Difficulty in napping
Important hyperacusis
Meniere's disease, fast fluctuating tinnitus (seconds or minutes), pulsatile tinnitus
Any patient benefiting of a tinnitus treatment that was modified in the last 3 months
Superficial wound, open or partially not cauterized

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 37 participants (actual)
Target follow-up: 17 Days
Patient registry: Yes

Groups and cohorts

Nap-modulated participants
Patients with rises of tinnitus intensity after taking a nap or after a short period of sleep. If possible with a characteristic ON/OFF tinnitus (sometimes they have a tinnitus for several days and then stop for several days also). This condition is determined by previous questionnaire.
Other: Napping

Interventions

OtherNapping
Patients are already equipped with electrodes when they pass a test battery before the nap to evaluate mechanisms potentially correlated with tinnitus modulation. Then they do a nap, the nap is stopped when several periods of sleep are seen on EEG (electroencephalogram). Then the test battery is done backwards to evaluate the same measures.

What researchers measure

Primary outcomes

Average change in minimum masking level of tinnitus (measured in dB)
Minimum masking level is measured with a wideband 20hz-12kHz noise before and after each nap of 5 minutes sleep.
Time frame: Average from 6 naps of 5 minutes sleep each over 2 days of participation

Secondary outcomes

Correlation between sleep apnea index (number of apnea/hyponea events per hour) and change in minimum masking level of tinnitus (measured in dB)
Sleep apnea index is measured during naps using plethysmography and using air flow measurements through cannulas.
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between muscular tension (Electromyogram + Trigger Points) and change in minimum masking level of tinnitus (measured in dB)
Using electromyogram on suprahyoid and masseter muscles, trigger points are done searching for muscle nodes
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between Middle ear mobility (Impedancemetry) and change in minimum masking level of tinnitus (measured in dB)
Using a multi-frequency impedancemeter
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between tubal function (Tubomanometry) and change in minimum masking level of tinnitus (measured in dB)
Using tubomanometer, the eustachian tube is controled (what pressure through the noise is needed)
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between articular dysfunction (Physiotherapy Tests) and change in minimum masking level of tinnitus (measured in dB)
Using cervical rotation test + adapted spurling test + jaw mobility in antepulsion and diduction
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between change in averaged electroencephalogram alpha band power and change in minimum masking level of tinnitus (measured in dB)
Difference of alpha band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between change in averaged electroencephalogram delta band power and change in minimum masking level of tinnitus (measured in dB)
Difference of delta band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between change in averaged electroencephalogram theta band power and change in minimum masking level of tinnitus (measured in dB)
Difference of theta band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between change in averaged electroencephalogram beta band power and change in minimum masking level of tinnitus (measured in dB)
Difference of beta band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation between change in averaged electroencephalogram gamma band power and change in minimum masking level of tinnitus (measured in dB)
Difference of gamma band power in the EEG signal averaged on the whole scalp between the resting state of 90s before the 5 minutes nap and the one after.
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation
Correlation coefficient between audition thresholds (Audiogram) values and change in minimum masking level of tinnitus (measured in dB)
Using an audiometer
Time frame: 6 naps of 5 minutes sleep each over 2 days of participation

Study locations

1 site

Hôpital Hôtel-Dieu
Paris, 75004, France

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Sep 2022, 3 months.

Of 20 observational studies under Tinnitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 78. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: May 24, 2022
First posted: Jul 20, 2022
StartActual: Jun 9, 2022
Primary completionActual: Sep 15, 2022
CompletionActual: Mar 10, 2023
Last update: Mar 29, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05467059
Lead sponsor: Robin Guillard EIRL
Collaborators: Fondation Lopez-Loreta, Service du sommeil de l'hôpital de l'Hôtel-Dieu
Responsible party: Sponsor
First posted: Jul 20, 2022
Start date: Jun 9, 2022
Primary completion: Sep 15, 2022
Completion: Mar 10, 2023
Last update: Mar 29, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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